Question 1

Who is the manufacturer of NOMAD (BASE UNIT/PORTABLE UNIT)?

Accepted Answer

Minnesota Valley Engineering, Inc. filed the 510(k) submission for NOMAD (BASE UNIT/PORTABLE UNIT) (K872449).

Question 2

What is the FDA product code for NOMAD (BASE UNIT/PORTABLE UNIT)?

Accepted Answer

BYJ. It is classified under 21 CFR 868.5655 as a Class 2 device in the Anesthesiology panel.

Question 3

When was NOMAD (BASE UNIT/PORTABLE UNIT) cleared by the FDA?

Accepted Answer

Jul 21, 1987 (decision: SESE).

Question 4

What is the regulatory pathway for NOMAD (BASE UNIT/PORTABLE UNIT)?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like NOMAD (BASE UNIT/PORTABLE UNIT)?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K872449
Device Name	NOMAD (BASE UNIT/PORTABLE UNIT)
Applicant	Minnesota Valley Engineering, Inc.
Product Code	BYJ · Anesthesiology
Decision Date	Jul 21, 1987
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.5655
Device Class	Class 2

NOMAD (BASE UNIT/PORTABLE UNIT)

Device Facts

Regulatory Classification

Identification